A Short Update on Sugammadex with a Special Focus on Economic
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a & hesi C st lin e ic n a A l f R o e l s Journal of Anesthesia & Clinical e a a n r r Zaouter et al., J Anesth Clin Res 2017, 8:7 c u h o J DOI: 10.4172/2155-6148.1000740 ISSN: 2155-6148 Research Review Article Open Access A Short Update on Sugammadex with a Special Focus on Economic Assessment of its Use in North America Cedrick Zaouter1*, Stefano Mion1, Alessandra Palomba2 and Thomas M Hemmerling3 1CHU de Bordeaux, Service d Anesthésie-Réanimation II, F-33000 Bordeaux, France 2University of Pisa, Pisa, Italy 3Department of Anesthesia, Division of Experimental Surgery, McGill University, Montreal, Canada *Corresponding author: Cedrick Zaouter, CHU de Bordeaux, Service d Anesthésie-Réanimation II, F-33000 Bordeaux, France, Tel: +33-5-57-65-68-66; Fax: +33-5-57-65-68-11; E-mail: [email protected] Received date: Jun 06, 2017; Accepted date: Jul 01, 2017; Published date: Jul 04, 2017 Copyright: © 2017 Zaouter C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Sugammadex offers significant advantages over the current anticholinesterase reversal drugs. Sugammadex used has been approved for the United Stated and for Canada since December 2015 and February 2016, respectively. The present article aims to provide a straightforward and concise review of the most recent literature describing its clinical advantages in routine use. A thorough and cost-effective evaluation has been conducted specifically for North America to determine if its price justifies its inclusion into regular patients’ care. The search examined the relevant literature from January 2013 to October 2016. The present narrative review describes how sugammadex could play a crucial role in the modern conduct of anesthesia. The particular emphasis on sugammadex cost-effective analysis performed in this article suggests that this new reversal agent should be considered for a wider use in North America. Keywords: Gamma-cyclodextrins; Reversal agent; Delayed examining the literature during the past four years (from January 2013 emergence from anesthesia; Drug-related side effects and adverse to October 2016). The cut-off time for this review was chosen to assess reactions, Anaphylaxis, Cost-benefit analysis and compile the most recent knowledge on the use, advantages, safety and economic viability of sugammadex. Then, the article focused with Introduction particular attention on the economic viability in North America simulating its use and the related cost-effectiveness in concrete clinical Worldwide, neuromuscular blockade (NMB) is reversed mostly with scenarios to determine whether its cost justifies its inclusion into neostigmine, an anticholinesterase drug. However, this association of routine care. medications encompasses several threatening side effects, such as arrhythmias [1] and bronchospasms, when neostigmine outlasts the Objectives of the present review: vagolytic action of the anticholinergic agents [2]. Also, neostigmine has After reading this review, the reader should be able to: noteworthy flaws such as a slow onset of action, as well as the impossibility to reverse deep NMB. In addition, high doses of 1. Prescribe the appropriate dose of sugammadex according to the neostigmine could trigger muscle weakness and consequently depth of NMB and according to the characteristics of particular respiratory complication [3,4]. Sugammadex is a modified cyclic population groups. oligosaccharide that embraces all the characteristics of an ideal NMB 2. Have a thorough understanding of sugammadex intraoperative reversal agent. It is a ring-shaped molecule with hydrophilic properties and postoperative advantages. on its outside allowing it to be water-soluble. The inner side is hydrophobic which attracts amino-steroidal neuromuscular blocking 3. Have a thorough understanding of sugammadex’s safety profile. agents (NMBA) [5]. Rapid plasmatic amino steroidal muscle relaxant 4. Have a critical judgment on the benefit to integrate sugammadex encapsulation creates a concentration gradient that extracts NMBA into clinical practice not only for patients’ safety purposes but also for molecules from the neuromuscular junction to shift back to the economic advantages. plasma. These features result in a significantly faster and safer reversal compared to standard anticholinesterase drugs [6]. Microcalorimetry Which is The Right Dose of Sugammadex According to tests have demonstrated that bonds with rocuronium are preserved for a longer period with a lower dissociation rate than vecuronium [7]. The Depth of The Nmb and How Long Does it Take to Consequently, rocuronium is the most common NMBA administered Fully Reverse Nmb in Comparison to Neostigmine? when sugammadex is used as a reversal agent. From its approval, sugammadex has been used in almost 60 countries, and over 15 Superficial/shallow neuromuscular block (reappearance of million doses have been administered [8]. Since December 2015 and the fourth twitch) February 2016, sugammadex is available in the United-States and Canada, respectively. Thus, the present paper reviews the clinical use of Sugammadex has been shown to be efficient in reversing superficial sugammadex providing readers a short but comprehensive overview. A block defined as a reappearance of 4 twitches after a train-of-four search of the PubMed database was conducted in November 2016, (TOF) with a ratio between the first response and the last one <0.4 [9]. J Anesth Clin Res, an open access journal Volume 8 • Issue 7 • 1000740 ISSN:2155-6148 Citation: Zaouter C, Mion S, Palomba A, Hemmerling TM (2017) A Short Update on Sugammadex with a Special Focus on Economic Assessment of its Use in North America. J Anesth Clin Res 8: 740. doi:10.4172/2155-6148.1000740 Page 2 of 10 In this clinical situation, 2 mgkg-1 sugammadex are sufficient to obtain NMB with significant time variability (TOF ratio ≥ 0.9 is obtained a TOF ratio ≥ 0.9 in less than 2 min. from 1.8 to 15.2 min) [17]. At present, we recommend 4 mgkg-1 sugammadex to reverse deep NMB in order to obtain a TOF ratio ≥ 0.9 Moderate neuromuscular blockade (TOF count 1 to 3) within 2 min. Sugammadex is also effective in reversing quickly moderate NMB Profound neuromuscular blockade (can’t intubate, can’t defined as a TOF count of 2 [10]. In 98 patients recruited in a multicenter randomized trial with moderate levels of NMB, Blobner et ventilate scenario) al. [11] found that the mean length of time necessary to obtain a TOF Sugammadex is also effective for urgent reversal in emergency ratio of 0.9 with 2.0 mgkg-1 sugammadex was 1.5 min, whereas 18.6 situations such as ‘can’t intubate, can’t ventilate’ even when a high-dose min were required with 50 µgkg-1 of neostigmine. Blobner and of rocuronium is administered. Chambers et al. [18] performed a collaborators have also shown that predictability of response was systematic review and found three randomized clinical trials that greater with sugammadex than neostigmine, with 98% of sugammadex compared 16 mg.kg-1 sugammadex with placebo or succinylcholine. In patients versus only 11% of neostigmine patients recovering to a TOF these trials, sugammadex was administered 3 or 5 min after 1 or 1.2 ratio of 0.9 within 5 min [11]. Interestingly, the efficacy to reverse mgkg-1 rocuronium, respectively. Chambers et al. [18] concluded that moderate NMB does not differ whether anesthesia is maintained with after a profound NMB, recovery of neuromuscular transmission after halogenated agents or with propofol [12]. Sugammadex has also been sugammadex was markedly faster than after placebo or than shown to reverse efficiently rocuronium moderate NMB in both spontaneous recovery from succinylcholine. Lee et al. [19] are the only Caucasian and Chinese subjects [13]. ones to compare the time to recover to a TOF ratio ≥ 0.9 between the -1 -1 Therefore, we recommend 2 mgkg-1 sugammadex to reverse administration of 1 mgkg succinylcholine and 16 mgkg sugammadex administered 3 min after an intubating dose of 1.2 moderately deep NMB (1 to 3 twitches present) in order to obtain a -1 TOF ratio ≥ 0.9 within 2 min. mgkg rocuronium. Time to recovery was significantly faster for the association rocuronium-sugammadex compared with succinylcholine with 4.4 ± 0.7 vs. 7.1 ± 1.6 min, respectively. In the rocuronium- Deep neuromuscular blockade (Post-Tetanic Count=1-2) sugammadex group, 87% of the patients reached a TOF ratio of 0.9 in One of the most compelling factors of sugammadex is its ability to less than 3 min, which was shorter than in the succinylcholine group reverse - reliably and quickly - deep NMB defined as 0 twitches after a by 4 to 5 min. Although sugammadex has been shown to be rapid and TOF stimulation or 1 to 2 twitches after a tetanic stimulation, Post- efficient to reverse rocuronium-induced profound NMB, it has been Tetanic Count=1-2 (PTC=1-2) [9,10]. Recently, Rahe-Meyer et al. [14] reported that it could require up to 17 min to fully reverse a profound enrolled patients from 10 different institutions in Germany. At the end block [20]. The reason is probably related to the wide range of of the surgery, 140 patients with a PTC=1-2 received randomly 4.0 individual responses and receptor affinity to a single dose of mgkg-1 sugammadex or placebo. Spontaneous recovery from deep rocuronium [21]. Nevertheless, it seems that there is an agreement that rocuronium-induced NMB is on average 40 times slower than rapid sequence induction (RSI) performed with the rocuronium- sugammadex. Four mgkg-1 sugammadex reversed deep NMB rapidly sugammadex association could bring some advantages [22,23]. The and consistently (2 min, interquartile 1.6-2.8 min). When neostigmine combination is compelling especially because it does not induce is used to reverse deep NMB, a mean of 50.4 min is necessary to reach fasciculations, which increase oxygen consumption during apnea [24].